MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC; LAVAGE, JET

Model Number	00-5150-175-00
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Questionable sterility issue: a hair was found in the inner sterile package of a pulsavac high capacity fan spray tip.Packaging and hair retained.

• Brand Name: PULSAVAC
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio ave.; dover OH 44622
• MDR Report Key: 9853189
• Report Number: 9853189
• Device Sequence Number: 16810208
• Product Code: FQH
• UDI-Device Identifier: 00889024374942
• UDI-Public: (01)00889024374942(17)210930(10)64159758
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2020
• Report Date (Section F): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 00-5150-175-00
• Device Catalogue Number: 00-5150-175-00
• Device Lot Number: 64159758
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/18/2020